Cerebral Oxygenation and Neurological Functioning After Cardiac Surgery (CONFUSE)

December 19, 2023 updated by: Dr. Gordon Boyd
The overall goal of this research program is to determine quantitative predictors of quantitative long-term neurological functioning following different cardiac surgery procedures. The investigators aim to generate a timeline of neurological function that includes pre-existing performance, post-operative delirium, and neurological outcome. Furthermore, the investigators will test the hypothesis that intraoperative regional cerebral oxygenation (rSO2) desaturations, as measured by near-infrared spectroscopy (NIRS) are associated with poor neurological functioning following cardiac surgery, as measured by a robotic device called the KINARM.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: J. Gordon Boyd, MD, PhD
  • Phone Number: 6135392754
  • Email: 2jgb1@queensu.ca

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L3V7
        • Recruiting
        • Kingston General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient undergoing non-emergent surgery will be recruited from the perioperative assessment clinic by a trained researcher.

Description

Inclusion Criteria:

  • adult patients undergoing coronary artery bypass surgery +/- valvular surgery

Exclusion Criteria:

  • pre-existing cognitive impairment or neurodegenerative condition
  • any reason that participant cannot participate in follow up (lives too far away, limb amputation, speaks language other than english)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cardiac surgery
Patients undergoing non-emergent cardiac surgery for coronary bypass graft and/or valvular replacement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
12 month cognitive outcome-Repeatable Battery of Neuropsychological Status (RBANS) Total Scale
Time Frame: 12 months
Participants will be assessed with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS assesses 5 cognitive domains (language, visuospatial, immediate memory, delayed memory, and attention). The individual domain scores are compiled to provide at total cognitive score (Total Scale), which is age-adjusted. The population normative value is 100 +/- 24 (1.96 SD).
12 months
12 month cognitive outcome-KINARM robotic assessment-visually guided reaching
Time Frame: 12 months
This centre-out reaching task assesses basic visuospatial skills and sensorimotor control. The subject's hand is represented by a white dot. Each subject is then instructed to bring the white dot quickly and accurately to the red target as they appear on the screen. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 months
12 month cognitive outcome-KINARM robotic assessment-arm position matching
Time Frame: 12 months
Patients are instructed to mirror-match the movement and final position of the robot-controlled arm. This task is performed twice to obtain data on both arms. Patients will require intact proprioceptive functioning to process information on where their limb is in the horizontal space. This arm position matching task has been shown to determine the degree of position sense impairment in subjects following stroke. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 months
12 month cognitive outcome-KINARM robotic assessment-reverse visually guided reaching
Time Frame: 12 months
This task is presented similarly to the visual guided reaching task. However, the movement of the white dot is now reversed compared to the movement of the patient's hand. To successfully complete the task, patients must move their hand away from the target, thereby reaching the red target with the white dot. This is a more complex reaching task, requiring inhibitory control to not automatically reach towards the red target and a cognitive rule to move the white cursor by moving in the opposite direction. Visuomotor impairments of this nature have been described in individuals at risk of developing Alzheimer's disease. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 months
12 month cognitive outcome-KINARM robotic assessment-ball on bar
Time Frame: 12 months
Patients are instructed to use a virtual bar, generated between their hands, to balance a virtual ball as it appears on the screen. The subject must then bring the balanced ball on bar to different target locations in virtual space. This task consists of three levels: 1) ball fixed to bar, 2) ball moves along bar based on bar orientation, 3) ball can roll freely along bar. This task assesses bimanual motor control. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 months
12 month cognitive outcome-KINARM robotic assessment-object hit
Time Frame: 12 months
In this task, the participants' hands are represented by paddles. Subjects are instructed to hit balls falling down from the top of the screen towards them. As the task progresses, the balls begin to fall more frequently and increase in speed, making the task gradually more difficult. This simple task measures sensorimotor function and decision-making. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 months
12 month cognitive outcome-KINARM robotic assessment-object hit and avoid
Time Frame: 12 months
This task is similar to the object hit task, where patients use the robot's handles to hit objects falling from the top of the screen towards them. In this task however, patients are instructed to only hit two target shapes while avoiding all other shapes (i.e distractors). The Object hit & avoid task therefore requires additional cognitive functions related to attention to identify each shape and inhibitory control to avoid the distractors. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 months
12 month cognitive outcome-KINARM robotic assessment-spatial span
Time Frame: 12 months
A series of squares light up on the screen in a particular sequence. Within a 3-by-4 grid of squares, patients are required to replay the sequence by reaching with their dominant hand to the correct squares. This task assesses visuospatial working memory, and is similar to the Corsi block-tapping task. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 months
12 month cognitive outcome-KINARM robotic assessment-trail making
Time Frame: 12 months
This task is a quantitative version of the standard pen-and-paper neuropsychological test. In trailing making part A, patients are instructed to connect the numbers 1 through 25. The trail making part B task requires subjects to connect the dots by alternating numbers and letters (1-A-2-B-3-C, etc.). This task assesses executive function related to task switching. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive trajectory (changes in KINARM and RBANS performance from pre-surgery, to 3- and 12-months post-operative)
Time Frame: Pre-operative, 3 months post-operative, and 12-months post-operative
This will be assessed with the KINARM robot and the RBANS (described above)
Pre-operative, 3 months post-operative, and 12-months post-operative
Physiological determinants of rSO2
Time Frame: Intraoperative (3-6 hours)
Intraoperative hemodynamic and physiological variables will be collected during the operation (eg. mean arterial pressure (mmHg), heart rate (beats per minute), peripheral oxygen saturation (%)) to determine the predictors of rSO2. A linear model will be created to demonstrate the relative contribution each of these predictors has to cerebral oxygenation (rSO2-single outcome variable).
Intraoperative (3-6 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Gordon Boyd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: J. Gordon Boyd, MD, PhD, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DMED-1672-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will be willing to share IPD following the publication of our study in peer reviewed literature.

IPD Sharing Time Frame

Following publication of our study, our data will be available for 5 years.

IPD Sharing Access Criteria

Study PI can be contacted via email for data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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